Protocol summary
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Study aim
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Researching the effect of cooperative learning with mobile phones on the sexual behavior of women involved in emotional divorce
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Design
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The clinical trial has a randomized control group, an intervention group, and a control group of 38 people each, randomization by 4 blocks method.
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Settings and conduct
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1. Eligible people will be selected by attending the research environment (Kosar Hospital Clinic and Qazvin Health Centers), using the Emotional Divorce Questionnaire, and in the next step, an initial assessment will be done using the Sexual Behavior Questionnaire, and they will be invited to participate in the research. will be done
2. For the intervention group, collaborative learning sessions using mobile phones and in a social network during four weeks (a 60-90 minute session weekly) will be conducted by the researcher in groups of 6 to 8 people. For people in the control group, unrelated questions will be presented during the study.
3. Evaluation of the results, one month and three months after the intervention (the last session), follow-up will be done by completing the sexual behavior questionnaire by two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Iranian married women , who have scored at least 8 in the emotional divorce questionnaire. Participated group are between 15 and 49 years old, Be educated and Owning a smartphone.
Exclusion conditions: Are pregnant , Lactating women, menopause and affecting psychological or physical illness.
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Intervention groups
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The participants are randomly assigned to the control and intervention groups. The intervention group will learn the principles of sexual behavior and correcting misconceptions under the guidance of the researcher.
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Main outcome variables
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Sexual behavior
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221121056564N1
Registration date:
2023-07-02, 1402/04/11
Registration timing:
prospective
Last update:
2024-06-19, 1403/03/30
Update count:
3
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Registration date
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2023-07-02, 1402/04/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-08-21, 1402/05/30
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Expected recruitment end date
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2024-03-18, 1402/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of mobile collaborative learning on sexual behavior of women involved in emotional divorce
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Public title
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Mobile collaborative learning and sexual behavior of women involved in emotional divorce
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being married
Obtaining a score of at least 8 from the emotional divorce questionnaire
Being Iranian
Access to social media such as internet and smart phone
Willing to participate in the study
Being 15 to 49 years old
Exclusion criteria:
Pregnancy
Breastfeeding
Menopause
Affected by a specific physical or psychological illness
Taking drug that affected sexual performance
Unwillingness to continue participating
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation, will be done by random block method , using blocks of four. For this purpose, 19 blocks of four will be formed. The randomization unit, will be the participants. To construct the allocation sequence, each group is assigned a letter (A: intervention group, B: control group). Then, with the help of online methods and without personal intervention, the allocation sequence will be produced. To hide the allocation sequence, the sequence will be written on the sheets and will be placed in sealed envelopes respectively.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-01, 1401/12/10
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Ethics committee reference number
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IR.QUMS.REC.1401.338
Health conditions studied
1
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Description of health condition studied
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Female sexual behavior
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ICD-10 code
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Z70.8
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ICD-10 code description
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Other sex counseling
Primary outcomes
1
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Description
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Female Sexual Behavior
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Timepoint
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Before intervention, one month and three month after intervention
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Method of measurement
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The Sexual Behavior Assessment Questionnaire
Secondary outcomes
1
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Description
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Emotional divorce
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Timepoint
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Bifore intervention and after intervention and 12 week later
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Method of measurement
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Gutman Emotional divorce scales
Intervention groups
1
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Description
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Intervention group:The intervention will be conducted in the form of four sessions of 60 to 90 minutes on a weekly basis in groups of 6 to 8 people in virtual space by the researcher. The description of the sessions is as follows: the first session; including the introduction and statement of the problems and goals of collaborative learning and education and knowledge of sexual physiology and sexual motivation, the second session; Training to recognize sexual capacity, question and answer, discussion and summary of the third session; Recognizing sexual function and question and answer and summing up the fourth session; Knowing the sexual script, question and answer and summary.
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Category
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Behavior
2
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Description
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Control group: In order to comply with the principles of research ethics, after the second follow-up, if needed and desired, they can use an online training session on sexual health and intervention content
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information about the main outcome will be shared anonymously
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When the data will become available and for how long
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The data will be accessible after 6 to 12 months after publication
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To whom data/document is available
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Researchers of scientific institution
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Under which criteria data/document could be used
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Citing the source
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From where data/document is obtainable
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Correspondence with Nora sadat miralavi
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What processes are involved for a request to access data/document
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The application letter must include the name of the applicant,the scientific title of research or the desired article
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Comments
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